Tacrolimus (FK506) Study in Moderate to Severe Refractory Ulcerative Colitis Patients
Ulcerative Colitis
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative colitis, tacrolimus, FK506, treatment outcome
Eligibility Criteria
Inclusion Criteria: Moderate to severe refractory UC patients Disease activity: more than 4 times of stool a day, bloody stool, moderate to severe endoscopic finding Steroid resistance or dependence to meet at least one of the following condition:no efficacy with more than 40mg/day or 1mg/kg/day of steroid over at least 1 week, no efficacy with 30-40mg/day of steroid over at least 2 weeks,exacerbation along with steroid reduction Exclusion Criteria: Mild or fulminant type Renal failure patients, hepatic failure patients Patients taking 6-mercaptopurine, cyclosporin or other immunosuppressants within 12 weeks prior to entry Patients who received LCAP or GCAP within 2 weeks prior to entry Patients who changed the dose of steroid or started steroid within 2 weeks prior to entry. Patients who changed the dose of steroid or started steroid within 1 week prior to entry in case they received more than 40 mg/ day or 1mg/kg/day of steroid just before the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
1
2